Medical device and methods of use

ABSTRACT

Devices, systems, and methods are provided for breaking a kidney stone(s) into smaller particles, fragments, and/or stone dust; and removing the same from a patient. The medical device may include a tube having a distal end, a proximal end, a port located proximal of the distal end, and a length of the tube extending between the proximal end and the distal end. A first portion of the tube may be proximal of the port and have a first cross-sectional area, while a second portion of the tube may be distal of the port and have a second cross-sectional area smaller than the first cross-sectional area. A first lumen may extend from the proximal end to the distal end of the tube. A second lumen may in communication with the port to fluidly connect the proximal end of the tube with the port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62/288,780, filed Jan.29, 2016, which is herein incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to medical devices. Moreparticularly, the disclosure relates to medical devices used, forexample, in breaking objects into smaller particles, and removing theresulting particles from a patient. The disclosure also relates tomethods of using such devices.

BACKGROUND OF THE DISCLOSURE

The incidence of hospitalization for the removal of urinary calculi,commonly referred to as kidney stones, has been estimated at 200,000cases per year. A vast majority of these patients pass their stonesspontaneously; however, in the remainder, the kidney stone(s) becomeimpacted in the ureter, a muscle tube joining the kidney to the bladder.An impacted kidney stone is a source of intense pain and bleeding, asource of infection and, if a stone completely blocks the flow of urinefor any extended length of time, can cause the loss of a kidney.

Various methods have been utilized to break the stone into smallerfragments. One such method is stone dusting. Stone dusting is used bysome urologists to fragment and evacuate stones from a kidney and isoften performed by a Ureteroscope. Intense light energy from a laserwithin the Ureteroscope breaks the stone into increasingly smallerpieces. Rather than breaking up the stone into chunks, which are removedby baskets, dusting generates very small fragments that are capable ofbeing passed naturally. However, in some cases, these small stonefragments may not pass naturally. In theory, any of these small stonefragments that do not evacuate through natural urine flow, could be aseed for new stone growth. Thus, the application of suction may beemployed to remove the stone dust. Providing suction requires a lumenwith sufficient internal cross-sectional area to allow stone fragmentsand/or dust to pass through without clogging. Adding such a lumen to atraditional ureteroscope may increase the ureteroscope's cross-sectionto a size that is no longer capable of reaching the target kidney stone.For example, the kidney stone may be within the kidney, or,specifically, within a calyx of the kidney. Often, the space within thekidney and/or a calyx of the kidney is more limited than the spacewithin the ureter and is not large enough to accommodate a ureteroscopewith the added width of a suction lumen. The disclosure addresses theabove-mentioned process and other problems in the art.

SUMMARY OF THE DISCLOSURE

Aspects of the present disclosure provide methods for breaking an objectinto smaller particles and removing said particles from portions of thehuman body with limited space.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive.

In one example, a medical device may include a tube having a distal end,a proximal end, a port located proximal of the distal end, and a lengthof the tube extending between the proximal end and the distal end,wherein a first portion of the tube may be proximal of the port and mayhave a first cross-sectional area and a second portion of the tube maybe distal of the port and may have a second cross-sectional area smallerthan the first cross-sectional area; a first lumen may extend from theproximal end to the distal end of the tube, and a second lumen may be incommunication with the port and may be fluidly connecting the proximalend of the tube with the port.

Examples of the medical device may additionally and/or alternativelyinclude one or more other features. Features of the various examplesdescribed in the following may be combined unless explicitly stated tothe contrary. For example, the port may be distal to the proximal end bya distance of approximately half to approximately three-quarters thelength of the tube. A laser fiber may be disposed within the firstlumen. A fluid supply assembly may be connected to the first lumen. Thefirst lumen may be configured to simultaneously connect to a fluidsupply apparatus and a laser control. A laser may extend from the lasercontrol into the first lumen and to the distal end. A vacuum source maybe connected to the second lumen. The port may be angled relative to alongitudinal axis of the second lumen. An illumination device may extendthrough the tube. An imaging device may extend through the tube. Thefirst cross-sectional area may be approximately 3 mm to approximately 8mm. The second cross-sectional area may be approximately 2 mm toapproximately 5 mm. The port may be substantially crescent-shaped. Theport may be located approximately 5 cm to approximately 15 cm from thedistal end. The second lumen may terminate at the port.

In another example, a method of operating a medical device may includepositioning a distal end of a medical device at a target area, themedical device including a first lumen and a second lumen, wherein thesecond lumen is in fluid communication with a port and the port isproximal of the distal end of the medical device, supplying fluidthrough the first lumen, and applying suction through the second lumen.

Examples of the method of operating the medical device may additionallyand/or alternatively include one or more other features. For example,the port may be at least 10 cm from the distal end of the medicaldevice. The target area may be within a patient's kidney and the port ispositioned within the patient's ureter.

In another example, a medical device may include a tube having a distalend, a proximal end, and a port located at least approximately 10 cmfrom the distal end, a first lumen in communication with the distal endand fluidly connecting the distal end with a fluid supply assembly, anda second lumen in communication with the port and fluidly connecting avacuum source with the port.

Examples of the medical device may additionally and/or alternativelyinclude one or more other features. Features of the various examplesdescribed in the following may be combined unless explicitly stated tothe contrary. For example, the port may be at least partiallydistal-facing.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various examples and togetherwith the description, serve to explain the principles of the disclosure.

FIG. 1 illustrates an exemplary medical device, including a tube, ahandle portion, a fluid supply assembly, a laser source, an illuminationsource, an imaging apparatus, and a vacuum source;

FIG. 2 illustrates an exemplary cross-section of the tube taken at 1-1of FIG. 1 ;

FIG. 3 illustrates an exemplary cross-section of the tube taken at 2-2of FIG. 1 ;

FIG. 4 illustrates an exemplary medical device extending into apatient's body; and

FIG. 5 illustrates an exemplary operation of the medical device of FIG.1 .

DETAILED DESCRIPTION

Reference is now made in detail to examples of the present disclosure,examples of which are illustrated in the accompanying drawings. Whereverpossible, the same reference numbers will be used throughout thedrawings to refer to the same or like parts. The term “distal” refers toa position farther away from a user end of the device. The term“proximal” refers a position closer to the user end of the device. Asused herein, the terms “approximately” and “substantially” indicate arange of values within +/−5% of a stated value.

Overview

Aspects of the present disclosure relate to systems and methods forbreaking kidney stones into smaller particles and removing thoseparticles from a target area of a patient's body without adding to thecross-sectional width of the portion of the device entering the targetarea. The medical device described herein may work by positioning withinthe target area a distal end of a ureteroscope, while positioning asuction port of a suction lumen in a cavity and/or lumen of the bodyhaving greater space and located proximal of the target area. Forexample, a distal end of a ureteroscope may be positioned within thekidney, or more specifically, a calyx of the kidney, and the suctionport may be positioned within the ureter which is proximal to and,often, has more space than the kidney and/or calyx. A laser, disposedwithin a lumen of the ureteroscope and thus positioned within the targetarea, may be used to break up kidney stones into particles. Duringand/or after the laser process, the suction port, positioned proximallyof the target area, may vacuum the resulting particles from the body.

Though several examples herein describe the distal end of the medicaldevice within the kidney and the suction port within the ureter, thepresent disclosure should not be limited thereto. For example, while thedistal end of the medical device is within the kidney, the suction portmay be anywhere within the urinary tract that is proximal to the distalend of the medical device, including more proximal portions of thekidney, the bladder and/or the urethra. Additionally, the target areamay be any location. In some examples, the target area may be anywherewithin a urinary tract. The target area may be a site in the body wherea kidney stone is known or suspected to be located. For example, if akidney stone is detected within the ureter, the ureter (or portionthereof) may be the target area and the suction port may be positionedanywhere proximally of the target area, including but not limited to,more proximal portions of the ureter, the bladder, and/or the urethra.

DETAILED EXAMPLES

FIG. 1 illustrates an exemplary medical device 100 for removing stonefragments/dust while minimizing the diameter of the portion of thedevice that is disposed within the target area, e.g., the kidney. Thedevice 100 may include a tube 102. Tube 102 may be a hollow, flexible,elongate tube having a suction port 109, a proximal end 106, and adistal end 104. Tube 102 may further include having independent firstand second lumens 112 and 114. Proximal end 106 of tube 102 may becoupled to a handle portion 110. The handle portion 110 and/or theproximal end 106 of tube 102 may be attached to a laser control 130, afluid supply assembly 140, a vacuum source 150, an illumination source160, and/or an imaging apparatus 170.

A. The Handle Portion

Handle portion 110 can be attached to tube 102 by, for example, welding,a locking configuration, adhesive, or integrally formed with tube 102.The handle portion 110 may include a plurality of ports. For example, afirst port may place first lumen 112 of tube 102 in fluid communicationwith fluid supply assembly 140 and a second port may place second lumen114 of tube 102 in fluid communication vacuum source 150. Additionalports and lumens may be provided for supplying to distal end 104 of tube102 and/or a laser fiber coupled to laser control 130, illuminationdevice coupled to illumination source 160, and/or an imaging devicecoupled to the imaging apparatus 170. For example, first lumen 112 mayinclude two ports, a first for connecting the fluid supply assembly 140and a second for connecting laser fiber 120 and/or laser source 130. Thehandle portion 110 may include an actuating mechanism (not shown) toactuate one or more medical devices that may be located at the distalend 104 of tube 102. For example, the handle portion may include anactuating mechanism to power on or off the laser, the illuminationdevice, and/or the imaging device.

The fluid supply assembly 140 may be any device and/or devices that cansupply fluid (e.g., saline) to first lumen 112. The fluid supplyassembly 140 may include, but is not limited to, a fluid source, a pump,a control system, a heat exchanger, a filter, a temperature sensor, apressure sensor, a supply line, and/or various user input devices.

The vacuum source may be any device and/or devices that can providesuction to lumen 114 (e.g., house vacuum, vacuum pump, etc.). The vacuumsource 150 may provide suction and allow the operator to vary thesuction. The vacuum source 150 may be located near the patient or may belocated remotely (such as a vacuum source located on a wall). In someexamples, vacuum source 150 may be included in a single unit with fluidsupply assembly 140. For example, fluid supply assembly 140 and vacuumsource 150 may be the inlet and outlet, respectively, of a peristalticpump.

B. The Tube

As noted above, tube 102 may further include two independent lumens,first lumen 112 and second lumen 114. While two lumens are illustratedin FIG. 1 , tube 102 may include any number of lumens. The lumensincluded in tube 102 may be any size, shape, and/or in anyconfiguration. Exemplary cross-sections of tube 102 at two positionsalong its length, including first lumen 112 and/or second lumen 114 willbe described in further detail below with respect to FIGS. 2 and 3 .

First lumen 112 and/or second lumen 114 may include any suitablecoating. For example, first lumen 112 and/or second lumen 114 mayinclude a layer of lubricous material, for example, to facilitateinsertion of any instrument and/or device or prevent clogging of stonefragments/dust. First lumen 112 and/or second lumen 114 may be definedby elongate hollow lumens that extend within tube 102.

First lumen 112 may extend between proximal end 106 and distal 104.First lumen 112 may be open (e.g., open to a body cavity like a kidney)at the distal end 104 of tube 102 to allow introduction of a laser fiber120 and/or flow of irrigation fluid. The distal opening of first lumen112 may be substantially perpendicular to the tube (e.g., as shown inFIG. 5 ), may be tapered or angled, or may be in any other suitableshape, size, and/or orientation. The proximal end of first lumen 112 mayhave any shape or configuration. For example, first lumen 112 may havetwo openings or may fork at or near the proximal end 106 of tube 102.First lumen 112 may be configured in any way that would allow for firstlumen 112 to be simultaneously connected to fluid supply apparatus 140and laser control 130. This may allow laser fiber 120 to be disposedwithin first lumen 112 at the same time fluid is introduced throughfirst lumen 112.

Second lumen 114 may extend between proximal end 106 and suction port109. Second lumen 114 may be in fluid communication with vacuum source150 and suction port 109. Suction port 109 may be open (e.g., open to abody cavity like a ureter) to allow the application of suction throughsecond lumen 114. Suction port 109 may be distal of proximal end 106 bya distance no greater than between approximately half and approximatelythree-fourths of the length of tube 102 (e.g., from proximal end 106 todistal end 104), or no greater than approximately two-thirds of thelength of tube 102. In some examples, suction port 109 may be no lessthan between approximately 3 cm to approximately 15 cm from distal end104, or no less than approximately 10 cm from distal end 104. Portionsof tube 102 proximal to suction port 109 (e.g., first portion 105) oftube 102 may include both second lumen 114 and first lumen 112. Portionsof tube 102 distal of suction port 109 (e.g., second portion 107) mayinclude first lumen 112, but not include second lumen 114. As such, thecross-sectional area of first portion 105 of tube 102 may be larger thanthe cross-sectional area of second portion 107 of tube 102. For example,the cross-sectional area of first portion 105 of tube 102 may beapproximately 3 mm to approximately 8 mm, approximately 4 toapproximately 7 mm, or approximately 4 mm to approximately 6 mm and thecross-sectional area of second portion 107 of tube 102 may beapproximately 2 mm to approximately 5 mm, approximately 2.5 mm toapproximately 4.5 mm, or approximately 3 mm to approximately 4 mm.

In some examples, suction port 109 may be substantially or at leastpartially distal-facing. In some examples, suction port 109 may beangled relative to the longitudinal axis of second lumen 114. Forexample, at suction port 109, a wall of second lumen 114 that isopposite first lumen 112 may terminate proximal to a wall of secondlumen 114 that is adjacent to first lumen 112. The walls connecting thetwo may form an accurate angle with longitudinal axis of the secondlumen 114 between approximately 10 degrees and approximately 80 degrees,approximately 30 degrees and approximately 60 degrees, or approximately45 degrees. The cross-sectional shape of suction port 109 may be anyshape, including but not limited to a shape corresponding to thecross-sectional shape of second lumen 114 (as described further belowwith respect to FIG. 2 ). For example, as shown in FIG. 5 , suction port109 may be substantially crescent-shaped.

Tube 102 may be circular, ovoidal, irregular, and/or any shape suitableto enter a body. Further, first portion 105 of tube 102 may have thesame shape or a different shape than second portion 107 of tube 102. Forexample, both first portion 105 and second portion 107 of tube 102 maybe substantially circular or second portion 107 of tube 102 may besubstantially circular while first portion 105 of tube 102 may besubstantiality ovoidal or irregular (e.g., to accommodate second lumen114). Tube 102 may have a uniform shape from proximal end 106 to distalend 104. Additionally or alternatively, first portion 105 of tube 102may have a uniform shape from proximal end 106 to suction port 109and/or second portion 107 of tube 102 may have a uniform shape fromsuction port 109 to distal end 104. In some examples, tube 102 (and/orfirst portion 105 or second portion 107) may having a varying shape,such as a taper at the distal end to facilitate insertion within thebody.

Depending upon the particular implementation and intended use, thelength of tube 102 may vary. Similarly, depending upon the particularimplementation and intended use, tube 102 can be rigid along its entirelength, flexible along a portion of its length, or configured forflexure at only certain specified locations. In one example, tube 102may be flexible, adapted for flexible steering within bodily lumens, asunderstood in the art. For example, tube 102 can include a steeringsystem (not shown) to move at least a portion (e.g., distal end 104)up/down and/or side-to-side. Additional degrees of freedom, provided forexample via rotation, translational movement of tube 102, or additionalarticulation of bending sections, may also be implemented. Examples ofsuch steering systems may include at least one of or all of pulleys,control wires, gearing, and electrical actuators.

Tube 102 may be formed of any suitable material having sufficientflexibility to traverse body cavities and tracts. In general, tube 102may be made of any suitable material that is compatible with livingtissue or a living system. That is, the tube 102 may be non-toxic ornon-injurious, and it should not cause immunological reaction orrejection. In some examples, tube 102 may be made of polymetricelastomers, rubber tubing, and/or medically approved polyvinylchloridetubing. Polymeric elastomers may be, for example, EVA (Ethylene vinylacetate), silicone, polyurethane, and/or C-Flex.

Further, the tube 102 may include any suitable coating and/or covering.For example, the outer surface may include a layer of lubricous materialto facilitate insertion through a body lumen or surgical insertion.Further, tube 102 may be coated with a biocompatible material such asTeflon. To inhibit bacterial growth in the body cavity, tube 102 may becoated with an antibacterial coating. Further, an anti-inflammatorysubstance may also be applied to the outer surface of the tube 102, ifrequired.

As shown in FIG. 5 , tube 102 may be designed to impose minimum risk tothe surrounding tissues while in use. To this end, one or more portionsof tube 102 may include atraumatic geometrical structures, such asrounded or beveled terminal ends or faces (e.g., suction port 109 and/ordistal end 104), to reduce trauma and irritation to surrounding tissues.

Distal end 104 of tube 102 may include visualization devices such asimaging device 124 and/or an illumination device 126. These devices maybe connected to imaging apparatus 170 and illumination source 160,respectively. As shown below in FIG. 5 , imaging device 124 andillumination device 126 may be disposed on a distal facing surface oftube 102. These devices and/or connecting wires may extend within thetube 102 (e.g., within a wall that separates first lumen 112 and secondlumen 114). For example, imaging device 124 may be a digital camera andsignal and/or power lines may extend through tube 102. Illuminationdevice 126 may be an LED and/or a fiber may extend through tube 102. Insome examples, the light from illumination device 126 may be diffused inany way known in the art. In some examples, imaging device 124 and/or anillumination device 126 may attach to the distal end 104 using knowncoupling mechanisms. As illustrated herein, imaging device 124 and/or anillumination device 126 are separate and substantially circular, butimaging device 124 and/or an illumination device 126 are not limitedthereto. For example, imaging device 124 and/or illumination device 126may be any imaging device and/or illumination device known in the art.Imaging device 124 and/or an illumination device 126 may be integratedinto a single unit and/or one or both may be non-circular in shape,e.g., imaging device 126 may be substantially rectangular in shape.Additionally or alternatively, the visualization devices may bedetachably introduced into tube 102 through lumens, including firstlumen 112 and/or second lumen 114 when required. For example, theproximal end of first lumen 112 and/or second lumen 114 may be forked toallow introduction of additional devices as well as a connection toeither fluid supply apparatus 140 and/or vacuum source 150. Additionallyor alternatively, first lumen 112 and/or second lumen 114 may includeside port(s) at or near proximal end 106 for introduction of additionaldevices.

FIG. 2 illustrates a cross-sectional view of tube 102 depicting firstlumen 112, second lumen 114, imaging device 124, and illumination device126. This view may, for example, be at line 1-1 of FIG. 1 or proximalend 106 of tube 102. As shown, first lumen 112 may be a semi-circularshaped lumen and second lumen 114 may be an arc- or curved-shaped lumen,but the size and shape of first lumen 112 and/or second lumen 114 arenot limited thereto. For example, first lumen 112 and second lumen 114may have approximately the same cross-sectional shape and size. Eitherlumen may be configured to supply fluid, apply suction, or both. Lumen114 may be approximately 0.5 mm to approximately 2.5 mm, approximately0.5 mm to approximately 2 mm, or approximately 1 mm to approximately 2mm. Lumen 112 maybe approximately 2 mm in length by approximately 1 mmin breadth, approximately 2.5 mm by approximately 2.5 mm, approximately2 mm by approximately 1 mm, approximately 3 mm by approximately 2 mm,approximately 2.5 by approximately 1 mm, or approximately 3 mm byapproximately 1.5 mm.

FIG. 2 includes imaging device 124 and illumination device 126. Thesedevices may be attached to the distal end 104 of tube 102 using knowncoupling mechanisms. In some examples, elements 124 and 126 of FIG. 2may represent lumens for an imaging device and/or an illumination deviceto be introduced through and/or for necessary fibers/wires/etc. toextend through.

FIG. 3 illustrates a cross-sectional view of tube 101 depicting firstlumen 112, imaging device 124, and illumination device 126. This viewmay, for example, be at line 2-2 of FIG. 1 or distal end 104. As shown,second lumen 114 is not present, because, for example, second lumen 114terminates proximal to the cross-sectional view of FIG. 3 , e.g., atsuction port 109. As shown, tube 102 may include a generallysemi-circular lumen, first lumen 112. It should be noted that firstlumen 112 may have any shape or size. In the example illustrated in FIG.3 , first lumen 112 may be configured to provide medical instruments,supply fluid, and/or apply suction.

FIG. 3 includes imaging device 124 and illumination device 126. Thesedevices may be attached to the distal end 104 of tube 102 using knowncoupling mechanisms. In some examples, elements 124 and 126 of FIG. 3may represent lumens for an imaging device and/or an illumination deviceto be introduced through and/or for necessary fibers/wires/etc. toextend through.

C. Insertion and Operation of the Medical Device

Referring to FIG. 4 , a patient's urinary tract includes urethra 402,bladder 404, ureter 406, and kidney 408. As shown in FIG. 4 , kidney 408includes calyx 410, including major calyx and minor calyx. In someaspects of the present disclosure, the target area, e.g., the area inwhich particles, like kidney stones 470 and stone fragments 480, areknown or suspected to be located, may be within calyx 410 of the kidney408. Often, the space within kidney 408 and/or calyx 410 of the kidney408 is more limited than the space within the ureter 406. Referring toFIG. 4 , an operator (e.g., a doctor or other medical professional) mayinsert distal end 104 of device 100 into the patient's urethra 402. Theoperator may advance tube 102 so that distal end 104 passes into andthrough the urinary bladder 404, into and through ureter 406, and intocalyx 410 of kidney 408. As there is limited space with calyx 410 ofkidney 408, the operator may position first portion 105 of tube 102and/or suction port 109 in the larger ureter 406. The operator mayposition a distal opening of first lumen 112 proximate a target area. Atarget area may be a site where stones and/or stone fragments (e.g.,stone 470 and/or stone fragments 480) are known or suspected to belocated. An imaging device (e.g., imaging device 124) may be utilized todetermine the location of stone(s), as known in the art. The distal end104 may be adjusted so that first lumen 112 and/or any medicalinstruments (e.g., laser fiber 120 of FIG. 5 ) disposed within firstlumen 112 may be aimed at the located stone(s). Laser fiber 120 may thenbe introduced through first lumen 112 to distal end 104.

As shown in FIG. 5 , once the laser fiber is in a sufficient position toaim for the kidney stone, the operator may initiate a laser control tobreak up the kidney stone. FIG. 5 illustrates an enlarged, exemplarydistal end 104 of tube 102 in which laser fiber 120 is aimed at kidneystone 470. Laser fiber 120 may be introduced into a patient throughfirst lumen 112. Laser fiber 120 may be connected to and/or controlledby laser control 130. Laser fiber 120 may be utilized to break up kidneystones (e.g., kidney stone 470) into smaller stone fragments (e.g.,stone fragments/dust 480).

The operator may connect first lumen 112 to fluid supply assembly 140and/or may turn on previously connected fluid supply assembly 140 tointroduce fluid through first lumen 112 to the target area. The fluidsupply assembly 140 may then provide fluid, through first lumen 112, tothe distal end 104 of tube 102 and into kidney 408. In some examples,the fluid supplied is a saline solution, for example, 0.9% saline. Fluidsupply assembly 140 and laser control 130 may be separately orsimultaneously connected to first lumen 112. In addition, first lumen112 may provide a pathway other instruments (e.g., basket, grasper,etc.).

Before, after, or simultaneously with the operator turning on the fluidsupply assembly 140 to introduce fluid through first lumen 112 to thetarget area, the operator may turn on the suction (e.g., vacuum source150) to pull the stone fragments/dust 480 into second lumen 114. Thearrows in FIG. 5 illustrate an exemplary path of irrigation fluid fromfirst lumen 112 to second lumen 114. In the example illustrated in FIG.4 , suction port 109 is positioned within ureter 406. Thus, if kidneystone 470 is within kidney 408 when it is broken into stonefragments/dust 480, the stone fragments/dust may travel (e.g., naturallyor through suction) proximally from the site of treatment into the renalpelvis or into the ureter 406 and then be suctioned into suction port109 by the suction supplied by vacuum source 150 through second lumen114. The continuous flow of saline (saline column) along with the stonedust 480 in the ureter may prevent the wall of the ureter fromcollapsing and being sucked into the suction port 109. Further, in someexamples, the use of an automated fluid management device that maintainsa constant intrarenal pressure during the procedure will also preventureter collapse as insufflation consistency is optimized.

Depending on the size of the patient, the size of the ureter anatomy mayvary. In some examples, a portion of the ureter may be enlarged using aballoon dilator at the start of the procedure to ensure that the uretercan accommodate the tube 102. In some examples, suction port 109 may belocated in the renal pelvis where there is more room and where irrigantinsufflation will work better to maintain expansion of the ureter.

In some example, the fluid may be provided to first lumen 112 at avariety of flow rates. The fluid may be introduced in a continuous flowor pulsed. In some examples, the flow rate may be pulsed at a regularinterval, e.g., every few seconds. The pulsed flow may be a flow that iseither intermittently interrupted or simply reduced in rate on anintermittent basis. The flow rate may be pulsed at complex flow ratepatterns such as periodic and aperiodic oscillatory patterns. A pulsedflow may be created in any way. In one example, the pulse flow may becreated by a mechanical pump, e.g., a peristaltic pump. The mechanicalpump may apply and release pressure on the fluid at intervals.

The flow rate of the introduced fluid may be balanced with the flow ratecaused by the vacuum source. Balanced flow rates can be substantiallyequal, but need not be exactly equal. A balanced flow rate may be anyflow rate that prevents harm to the patient. For example, a balancedflow rate may be any flow rate of the introduction of fluid inrelationship to the flow rate of the suction that preventshydronephrosis and/or prevents the kidney from collapsing due to nofluid in the system, as known in the art. The balanced flow rate mayassist in maintaining a pressure equilibrium during operation of thedevice. In some examples, a pressure sensor may also be located at ornear the target area and/or distal end 104 to assist in maintaining apressure equilibrium.

In addition, the application of suction, e.g., suction through suctionport 109, may improve the ability to break kidney stones by creating ananti-retropulsion effect. By applying suction through second lumen 114,a kidney stone may be pulled toward laser fiber 120, thus countering theeffect of the laser energy pushing the kidney stone away. Thisconfiguration thus assists in generating the smaller stone fragments bypulling the stones into the reach of laser fiber 120. It may alsoimprove the suction of the resulting stone fragments into second lumen114 and out of the body. For example, by having irrigation from thedistal end and suction from a side of tube 102, the inflow fluid is lesslikely to interfere with the vacuuming of the stone dust. In addition,positioning suction port 109 within the ureter may prevent clogging ofsuction port 109 and/or second lumen 112. For example, larger stones maynot be capable of travelling into the ureter to reach suction port 109,because the entrance to the ureter is partially blocked by secondportion 107 of tube 102 and/or there is not sufficient space within theureter for larger (e.g., not broken up by a laser) stones.

Once the operator determines kidney stone 470 has been broken intosufficiently small fragments 480 (e.g., sufficiently small to passnaturally or to be suctioned into suction port 109) or does not want tocontinue for other reasons, the laser process may be stopped. Once thestone fragments/dust 480 have been sufficiently removed from the bodythrough suction port 109 and second lumen 114, the operator may ceaseintroduction of irrigational fluid and/or stop suction. In some example,the laser process, introduction of irrigational fluid, and/orapplication suction may all stop at the same time. In other examples,introduction of irrigational fluid and/or suction may continue after thelaser process has stopped.

In some examples, fluid supply assembly 140 and/or vacuum source 150 donot operate at the same time as laser fiber 120. For example, the laserprocess may cease before introduction of fluid through first lumen 112and/or application of suction through second lumen 114. In someexamples, laser fiber 120 may be removed from first lumen 112 beforefluid is introduced through first lumen 112.

At any point, an operator may additionally choose to move the devicewithin the patient. For example, an operator may choose to move distalend 104 of tube 102 to the site of an additional kidney stones. Thepurpose of repositioning the distal end 104 may be to reach stones orstone fragments that need to be broken into smaller pieces. In someexamples, the operator may choose to move tube 102 so that suction port109 is positioned at a location in which additional stone fragments/dusthave accumulated. The purpose of repositioning suction port 109 may beto reach stone fragments/dust that the device was previously unable tosuction out. For example, some stone fragments/dust may be positionedproximally to suction port 109 or positioned too distally to be capturedby applied suction. An operator may reposition tube 102 any number oftimes. Once repositioned, any or all of the previously described steps,e.g., the laser process, introduction of fluid, and/or application ofsuction, may be repeated at the new location.

Once an operator determines no more kidney stones can and/or should bebroken apart and/or no more stone fragments/dust can and/or should beremoved, the ureteroscope (e.g., tube 102) may be removed from thepatient's body.

The many features of the disclosure are apparent from the detailedspecification, and thus, it is intended by the appended claims to coverall such features of the disclosure which fall within the true spiritand scope of the disclosure. Further, since numerous modifications andvariations will readily occur to those skilled in the art, it is notdesired to limit the disclosure to the exact construction and operationillustrated and described, and accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thedisclosure.

Other aspects of the disclosure will be apparent to those skilled in theart from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1-20. (canceled)
 21. A medical device comprising: a tube extending froma proximal end to a distal end and including a port proximal to thedistal end, wherein a first section of the tube proximal of the port hasa first cross-sectional area and a second section of the tube distal ofthe port has a second cross-sectional area smaller than the firstcross-sectional area; a first lumen extending from the proximal end tothe distal end of the tube and terminating at a distal opening, whereinthe distal opening is at a fixed distance from the port; a second lumenin communication with the port and fluidly connecting the proximal endof the tube with the port, wherein the second lumen extends adjacent tothe first lumen in the first section of the tube; and a laser fiberdisposed within the first lumen and movable distally through the distalopening.
 22. The medical device of claim 21, wherein the secondcross-sectional area includes a cross-section of one less lumen than thefirst cross-sectional area.
 23. The medical device of claim 21, whereinthe first section of the tube defines an outermost wall of each of thefirst lumen and the second lumen.
 24. The medical device of claim 21,wherein a position of the first lumen is fixed relative to a position ofthe second lumen.
 25. The medical device of claim 21, wherein the portis located approximately 3 cm to approximately 15 cm from the distalopening.
 26. The medical device of claim 21, further comprising a handlecoupled to the proximal end of the tube, the handle comprising at leastone port in communication with the first lumen or the second lumen,wherein the at least one port is configured to connect to a fluidsupply, a laser control, or a vacuum source.
 27. The medical device ofclaim 21, wherein the second cross-sectional area does not include thesecond lumen.
 28. The medical device of claim 21, wherein the secondlumen terminates at the port.
 29. The medical device of claim 21,wherein the distal end of the tube includes an imaging device.
 30. Themedical device of claim 29, wherein the imaging device is configured toreceive power from connecting wires extending within a wall of the tubebetween the first lumen and the second lumen.
 31. The medical device ofclaim 21, wherein the second cross-sectional area is approximately 2.5mm to approximately 4.5 mm.
 32. The medical device of claim 21, whereinthe port is at least partially distal-facing.
 33. The medical device ofclaim 21, wherein the port is angled relative to a longitudinal axis ofthe second lumen.
 34. A medical device comprising: a tube having adistal end, a proximal end, and a port proximal to the distal end; afirst lumen extending within the tube and terminating at a distalopening defined by a distalmost face of the distal end of the tube; asecond lumen extending within the tube, wherein the second lumen is incommunication with the port; and an imaging device disposed on thedistalmost face of the distal end of the tube; wherein the port is at afixed distance from the distalmost face of the distal end of the tube.35. The medical device of claim 34, wherein the second lumen extendsadjacent to the first lumen in a first section of the tube proximal tothe port, and wherein the second lumen terminates at the port.
 36. Themedical device of claim 34, further comprising a laser fiber disposedwithin the first lumen and movable distally through the distal opening.37. The medical device of claim 34, further comprising an illuminationdevice disposed on the distalmost face of the distal end of the tube.38. The medical device of claim 34, wherein the imaging device isconfigured to receive power from connecting wires extending within awall of the tube.
 39. A medical device comprising: a tube having adistal end, a proximal end, and a port proximal to the distal end; afirst lumen extending through the tube from the proximal end of the tubeto a distal opening of the distal end of the tube; a second lumenextending adjacent to the first lumen through a section of the tube fromthe proximal end of the tube to the port and terminating at the port;and a laser fiber disposed within the first lumen and movable distallythrough distal opening.
 40. The medical device of claim 39, wherein thetube defines an outermost wall of each of the first lumen and the secondlumen.